Comparative Evaluation of Transcutaneous Electrical Nerve Stimulation With and Without Ginger Mouth wash in Type II Diabetes Mellitus Patients With Hyposalivation - A Clinical Trail
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Comparing the effectiveness of TENS With & Without Ginger Mouthwash in both Groups
研究概览
简要总结
Saliva plays a critical role in maintaining oral homeostasis. A decrease in salivary function, known as xerostomia, increases a patient’s risk for
caries and other oral infections. Palliative management of xerostomia includes wetting agents such as ice chips, drugs, and saliva substitutes.
Systemic agents stimulate salivary flow but often have unfavorable side effects. Modalities like Transcutaneous electric Nerve Stimulation, which
has fewer side effects have been used to stimulate salivary flow. The rhizome Zingiber officinale Roscoe, known as ginger, has been used as a spice
for over 2000 years. Various authors suggest that ginger has a potential effect in increasing the salivary flow rate. It is considered a safe food by US
Food and Drug Administration (FDA)
AIM
The aim of this study is to evaluate the effect of Transcutaneous Electric Nerve Stimulation along with ginger mouthwash on the salivary flow
rates of type 2 diabetes mellitus patients with reduced salivary secretion
OBJECTIVES
To estimate the salivary flow rate before and after ginger mouthwash usage in type 2 diabetes mellitus patients with reduced salivary secretion
To estimate the unstimulated whole salivary flow rate before Transcutaneous Electric Nerve Stimulation therapy and the stimulated whole
salivary flow rate after Transcutaneous Electric Nerve Stimulation therapy in type 2 diabetes mellitus patients with reduced salivary secretion
To evaluate the effectiveness of Transcutaneous Electric Nerve Stimulation with and without ginger mouthwash usage on the salivary flow rate of
type 2 diabetes mellitus patients with reduced salivary secretion
OUTCOME/SCOPE
The present study will find out whether the synergic effect of Transcutaneous Electric Nerve Stimulation and ginger mouthwash could be useful
in improving the reduced salivary secretion
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •40-65 years age group of patients Patients with fasting blood glucose level > 126mg/dl Patients undertaking diabetic medication Non-smokers Non-alcoholic.
排除标准
- •Individuals with pacemakers, defibrillators, hearing aids, and cochlear implants Individuals with salivary gland disease, endocrine disease, and psychogenic disease Neurologic disorders like stroke, parkinsonism, bell’s palsy, asthma, and epilepsy Pregnant women Individuals with systemic & autoimmune disease Individuals on medications (which produce dry mouth) Individuals on medications for salivary secretion improvement Radiation therapy undergone individuals for head & neck cancer Individuals with contact dermatitis Individuals who are allergic to ginger Individuals with adverse habits like smoking, tobacco & areca nut.
结局指标
主要结局
Comparing the effectiveness of TENS With & Without Ginger Mouthwash in both Groups
时间窗: Two months
次要结局
- To estimate the salivary flow rates in group 1 patients with hyposalivation undertaking ginger mouthwash & TENS therapy(To estimate the salivary flow rates in group 2 patients with hyposalivation undertaking distilled water and TENS therapy)